National Medical Policy

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1 National Medical Policy Subject: Policy Number: Robotic Surgery NMP207 Effective Date*: March 2005 Updated: October 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State's Medicaid manual(s), publication(s), citations(s) and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link National Coverage Determination (NCD) National Coverage Manual Citation X Local Coverage Determination (LCD)* Cranial Stereotactic Radiosurgery (SRS) and Cranial Stereotactic Radiotherapy: Selective Internal Radiation Therapy (SIRT) for Primary and Secondary Hepatic Malignancy (90Y- Microsphere Hepatic Brachytherapy: Stereotactic Body Radiation Therapy: Stereotactic Radiation Therapy: Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT): Stereotactic Radiosurgery: Article (Local)* X Other MLN Matters Number: MM7443. Related CR Release Date: May 27, July 2011 Update of the Hospital Outpatient Prospective Payment System (OPPS). Billing for Linear Accelerator (Robotic Image-Guided and Non-Robotic Image-Guided) SRS Planning and Delivery: Robotic Surgery Oct 15 1

2 Education/Medicare-Learning-Network- MLN/MLNMattersArticles/downloads/MM7443.pdf MLN Matters Number: MM5438. Related CR Release Date: December 22, 2006, Updated October 31,2012. January 2007 Update of the Hospital Outpatient Prospective Payment System (OPPS): Summary of Payment Policy Changes and OPPS PRICER Logic Changes and Instructions for Updating the Outpatient Provider Specific File (OPSF): Education/Medicare-Learning-Network- MLN/MLNMattersArticles/downloads/MM5438.pdf None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Robotic- assisted surgery is proven as equivalent to, but not superior to, a standard minimally invasive surgical approach, where the standard minimally invasive surgical approach is itself supported by clinical evidence. It is a method of performing the procedure and not a separate service. Health Net does not provide additional reimbursement for the use of robotic surgical devices (e.g., da Vinci Surgical System, ZEUS Robotic Surgical System). The type of instruments, technique or approach used in a procedure is a matter of choice of the surgeon. Additional professional or technical reimbursement will not be made when a surgical procedure is performed using robotic assistance. Reimbursement for procedures in which a robotic surgical system is used will be based on the contracted rate or usual and customary fee for the base procedure. Separate reimbursement is not allowed for the robotic surgical technique. Reimbursement for the base procedure may be subject to medical necessity review. This policy includes any type of robotically assisted surgery such as prostate, cardiac, gastrointestinal, urology and gynecological etc. Robotic Surgery Oct 15 2

3 Please refer to Health Net Medical Policy on Computer Assisted Orthopedic Surgery regarding MAKOplasty Partial Knee Resurfacing or MAKOplasty total hip replacement using the Robotic Arm Interactive Orthopedic System (RIO). Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date. ICD-9 Codes To numerous to list CPT Codes To numerous to list HCPCS Codes S2900 Surgical techniques requiring use of robotic surgical system (list separately in addition to code for primary procedure) Scientific Rationale Update October 2015 Chan et al (2015) compared the complications and charges of robotic vs. laparoscopic vs. open surgeries in morbidly obese patients treated for endometrial cancer. Data were obtained from the Nationwide Inpatient Sample from Chisquared, Wilcoxon rank sum two-sample tests, and multivariate analyses were used for statistical analyses. Of 1,087 morbidly obese (BMI 40kg/m2) endometrial cancer patients (median age: 59 years, range: 22 to 89), 567 (52%) had open surgery (OS), 98 (9%) laparoscopic (LS), and 422 (39%) robotic surgery (RS). 23% of OS, 13% of LS, and 8% of RS patients experienced an intraoperative or postoperative complication including: blood transfusions, mechanical ventilation, urinary injury, gastrointestinal injury, wound debridement, infection, venous thromboembolism, and lymphedema (p<0.0001). RS and LS patients were less likely to receive blood transfusions compared to OS (5% and 6% vs. 14%, respectively; p<0.0001). The median lengths of hospitalization for OS, LS, and RS patients were 4, 1, and 1 days, respectively (p<0.0001). Median total charges associated with OS, LS, and RS were $39,281, $40,997, and $45,030 (p=0.037). The authors concluded in morbidly obese endometrial cancer patients, minimally invasive robotic or laparoscopic surgeries were associated with fewer complications and less days of hospitalization relative to open surgery. Compared to laparoscopic approach, robotic surgeries had comparable rates of complications but higher charges. Acar et al (2015) reported a comparative analysis between open and robotic nephron sparing surgeries (NSS) from a single institutional database. Patients who had undergone NSS at a single institution were included in the study. Open (n = 74) and Robotic Surgery Oct 15 3

4 robotic (n = 59) groups were compared regarding trifecta outcome. Trifecta was defined as; warm ischemia time (WIT) <25 min, negative surgical margins and the absence of perioperative complications. A total of 57 (77 %) and 45 (76 %) patients in the open and robotic groups, respectively achieved the trifecta outcome. Overall trifecta rate was 77 % (n = 102/133). The only statistically significant difference between trifecta positive and trifecta negative patients was the length of hospitalization (LOH). Except LOH; none of the tested parameters were shown to be predictive of trifecta outcome on univariate and multivariate analyses. Concerning trifecta positive patients; those in the open surgery group had larger tumors with a higher degree of morphometric complexity and were hospitalized for a longer period of time. Additionally, operative duration was significantly higher in the robotic group. The authors concluded in this cohort, no significant difference in achieving the trifecta outcome was reported after open and robotic NSS. Length of hospitalization was the only parameter that differed significantly between trifecta positive and trifecta negative patients. Surgical approach was not a significant predictor of simultaneous achievement of trifecta outcomes. Irrespective of the trifecta definition; larger and more complicated tumors were handled via open NSS. Corrado et al (2015) evaluated the surgical and oncological outcome of robotic hysterectomy (RH) plus or less pelvic and aortic lymphadenectomy in severely obese patients (BMI 40 kg/m2) with endometrial cancer. Between August 2010 and November 2014, patients with histologically confirmed endometrial cancer and BMI 40 kg/m2 were deemed eligible for the study and underwent RH plus or less pelvic and aortic lymphadenectomy. A total of 70 patients were divided into three groups according to their BMI: BMI between 40 and 45kg/m2 group A (50 patients), BMI between 45 and 50kg/m2 group B (10 patients) and BMI above 50kg/m2 group C (10 patients). No significant statistical differences were found between the three groups in terms of operative time, blood loss, hospital stay and oncological results. Pelvic lymphadenectomy was performed in 42%, 30% and 20% of patients in group A, B and C, respectively. Intra-operative complication occurred in one patient in group A, early postoperative complications in 4 patients in group A and in 1 patient in group C and late postoperative complication occurred in one patient in group A. No conversions to laparotomy were necessary while there were 3 conversions to laparoscopy in group A and 1 patient in both group B and C. The authors concluded the study showed that robotic surgery in severely obese patients with endometrial cancer is safe and feasible. Moreover, it seems that an increase in BMI does not change the surgical and oncological outcomes. However, randomized controlled trials are needed to confirm these results. Albreight et al (2015) conducted a systematic review and meta-analysis to assess the safety and effectiveness of robotic versus laparoscopic hysterectomy in women with benign uterine disease, as determined by randomized studies. The authors searched MEDLINE, EMBASE, the Cochrane Library, ClinicalTrials.gov, and Controlled-Trials.com from inception to October 9th, 2014, using the intersection of the themes "robotic" and "hysterectomy." The authors included only randomized and quasi-randomized controlled trials of robotic versus laparoscopic hysterectomy in women for benign disease. Four trials met inclusion criteria and were included in the analyses. Data was extracted and studies were assessed for methodological quality in duplicate. For meta-analysis, we used random effects to calculate pooled risk ratios (RR) and weighted mean differences. For our primary outcome, we used a modified version of the Expanded Accordion Severity Grading System to classify perioperative complications. The authors identified 41 total complications among 326 patients. When comparing robotic to laparoscopic hysterectomy, the authors found Robotic Surgery Oct 15 4

5 no statistically significant differences in the rate of class 1 and 2 complications (RR=0.66, 95% Confidence Interval (CI) ) or in the rate of class 3 and 4 complications (RR=0.99, 95%CI ). Analyses of secondary outcomes were limited due to heterogeneity, but showed no significant benefit of robotic compared to laparoscopic technique in terms of length of hospital stay (weighted mean difference= days, 95%CI ), total operating time (weighted mean difference=9.0 minutes, 95%CI ), conversions to laparotomy, or blood loss. Outcomes of cost, pain, and quality of life were inconsistently reported and not amenable to pooling. The authors concluded current evidence demonstrates neither statistically significant, nor clinically meaningful differences in surgical outcomes between robotic and laparoscopic hysterectomy for benign disease. The role of robotic surgery in benign gynecology remains unclear. Kahn et al (2015) compared the outcomes of patients undergoing open radical cystectomy (ORC), robot-assisted radical cystectomy (RARC), and laparoscopic radical cystectomy (LRC). From March 2009 to July 2012, 164 patients requiring radical cystectomy for muscle-invasive bladder cancer or high-risk non-muscleinvasive bladder cancer were invited to participate, with an aim of recruiting 47 patients into each arm. Overall, 93 were suitable for trial inclusion; 60 (65%) agreed and 33 (35%) declined. Primary end points were 30- and 90-d complication rates. Secondary end points were perioperative clinical, pathologic, and oncologic outcomes, and quality of life (QoL). The Fisher exact test and analysis of variance were used for statistical analyses. The 30-d complication rates (classified by the Clavien-Dindo system) varied significantly between the three arms (ORC: 70%; RARC: 55%; LRC: 26%; p=0.024). ORC complication rates were significantly higher than LRC (p<0.01). The 90-d complication rates did not differ significantly between the three arms (ORC: 70%; RARC: 55%; LRC 32%; p=0.068). Mean operative time was significantly longer in RARC compared with ORC or LRC. ORC resulted in a slower return to oral solids than RARC or LRC. There were no significant differences in QoL measures. Major limitations are the small sample size and potential surgeon bias. The authors concluded the 30-d complication rates varied by type of surgery and were significantly higher in the ORC arm than the LRC arm. There was no significant difference in 90-d Clavien-graded complication rates between the three arms. Shen et al (2015) reported robot-assisted gastrectomy (RAG) is a new minimally invasive surgical technique for gastric cancer. This study was designed to compare RAG with laparoscopy-assisted gastrectomy (LAG) in short-term surgical outcomes. Between October 2011 and August 2014, 423 patients underwent robotic or laparoscopic gastrectomy for gastric cancer: 93 RAG and 330 LAG. We performed a comparative analysis between RAG group and LAG group for clinicopathological characteristics and short-term surgical outcomes. RAG was associated with a longer operative time (P < 0.001), lower blood loss (P = 0.001), and more harvested lymph nodes (P = 0.047). Only three patients in LAG group had positive margins, and R0 resection rate for RAG and LAG was similar (P = 0.823). The RAG group had postoperative complications of 9.8 %, comparable with those of the LAG group (P = 0.927). Proximal margin, distal margin, hospital stay, days of first flatus, and days of eating liquid diet for RAG and LAG were similar. In the subgroup of serosa-negative patients, RAG had a longer operation time (P = 0.003), less intraoperative blood loss (P = 0.005), and more harvested lymph nodes (P = 0.04). However, in the subgroup of serosa-positive patients, RAG had a longer operation time (P = 0.001), but no less intraoperative blood loss (P = 0.139) and no more harvested lymph nodes (P = 0.139). Similarly, in the subgroup of total gastrectomy patients, RAG had a longer Robotic Surgery Oct 15 5

6 operation time (P = 0.018), but no less intraoperative blood loss (P = 0.173). The authors concluded the comparative study demonstrates that RAG is as acceptable as LAG in terms of surgical and oncologic outcomes. With lower estimated blood loss, acceptable complications, and radical resection, RAG is a promising approach for the treatment of gastric cancer. However, the indication of patients for RAG is critical. Arms et al (2015) reported that there are well-described benefits to minimally invasive surgery including decreased blood loss, shorter hospital-stay, and faster recovery. The role of robotic surgery in gynecologic oncology has become increasingly prominent; however limited data are available on quality of life (QOL) after robotic surgery. In a prospective, IRB-approved study, women scheduled for robotic surgery for a gynecologic indication between May 2008 and February 2012 completed validated QOL measures at baseline, 6weeks (6wk), and 4months postoperative (4mo). Functional status (SF-12), symptom severity and interference (MDASI), sexual function (FSFI), and satisfaction with decision (SWD) were assessed at relevant time points. Differences between groups were evaluated using the Mann- Whitney test. Among 408 women who underwent robotic surgery 278 (68%) completed the QOL measures. Median age was 55.6years (range ). Median BMI was 31.3kg/m(2). The majority of patients were white (75%). The most common indication for surgery was endometrial cancer/hyperplasia (59.7%). While physical functioning declined from baseline to 6wk (51.4 to 41.6, p<0.001), it improved by 4mo (53.5). Mental functioning improved over time (baseline 48.6, 6wk 52.8, and 4mo 55.6, p<0.001). Symptom severity decreased over time (p<0.001) as did symptom interference (p<0.001). Sexual function improved significantly from baseline (8.6) to 4mo (20.2, p<0.001). Patients were satisfied with their decision making (SWD=30). The authors concluded in this prospective study, general health, symptom burden and sexual function returned to or improved beyond baseline levels within 6weeks of surgery. Overall, women were satisfied with their decision to undergo robotic surgery. Scientific Rationale Update October 2014 Xiao et al (2014) reported on a large group of patients who underwent totally robotic atrial septal defect (ASD) repair on an arrested or beating heart at a single institution with a 7-year follow-up. From 2007 to 2013, 160 patients (median age, 36 years; range, years) at a single center underwent selective repair of secundum-type ASD using the da Vinci robotic system. The first 54 cases were performed on an arrested heart (arrested-heart group, n = 54) and the remainder on a beating heart (beating-heart group, n = 106). The mean diameter of defects was 2.9 cm (range, cm). Cardiopulmonary bypass was achieved via cannulation of the femoral vessels and the right internal jugular vein. Blood cardioplegic arrest was induced using a transthoracic Chitwood clamp in the arrested-heart group. With the assistance of a robotic surgical system, atrial septal defect repairs were performed with or without tricuspid valvuloplasty via three 8-mm ports, a camera port and a working port in the right chest. Transoesophageal echocardiography was used to evaluate surgical results and follow-up. Complete ASD closure was verified by intraoperative transoesophageal echocardiography in all patients. None of the procedures was converted to an alternate technique and there were no major complications. There were significant learning curves for cross-clamp time, operative duration and cardiopulmonary bypass time. The beating-heart group had significantly shorter operative and cardiopulmonary bypass durations than the arrested-heart group (P = 0.000). The two groups had similar durations of mechanical ventilation and intensive care unit and hospital stays, and similar drainage volumes. During the 39 ± 21 months of follow-up, no patient required reoperation because of a residual Robotic Surgery Oct 15 6

7 shunt or tricuspid valve regurgitation. The authors concluded ASD can be performed safely and effectively on an arrested or beating heart with the assistance of robotic technology. This totally endoscopic approach represents an option for patients seeking a reliable, minimally invasive ASD repair with an excellent long-term result. Maddox et al (2014) examined the intermediate oncologic and functional outcomes of robotic partial nephrectomy for clinical T1b tumors noting that partial nephrectomy has become the gold standard of treatment for small renal masses. Recently, indications for minimally invasive partial nephrectomy have extended to larger and more complicated renal masses in some centers. Between July 2008 and September 2013, 241 robotic partial nephrectomies were performed at a single institution, including 46 for clinical T1b tumors. The authors reviewed the intermediate-term functional and oncologic outcomes of this cohort of patients. Of the 46 patients, the median age was 55.5 years (interquartile range [IQR], years) with a median body mass index of 31.6 (IQR, ), tumor diameter of 5.0 cm (IQR, cm), and RENAL nephrometry score of 7.1 (range, 5-11). Renal cell carcinoma was confirmed in 35 patients, and 11 patients had benign pathology. There was 1 patient with an established positive margin and 2 patients had a focal positive margin. At a median follow-up of 24.3 months (range, months), the overall, recurrence-free and cancer-specific survival was 97.1%, 97.1%, and 100%, respectively. No patient progressed to dialysis postoperatively and there was no significant difference between preoperative and postoperative serum creatinine or estimated glomerular filtration rate using the Modification of Diet in Renal Disease equation. The authors concluded because of the many adverse medical effects of chronic renal insufficiency, the indications for partial nephrectomy are expanding at many institutions. The y noted they demonstrated that robotic partial nephrectomy is a safe and efficacious procedure for the treatment of T1b renal tumors with excellent intermediate oncologic and functional outcomes. Yoo et al (2014) reviewed a single-center experience on robotic mitral valve repair to treat mitral regurgitation, with a specific focus on midterm echocardiographic mitral durability. No data assessing the quality or durability of repaired mitral valves are currently available. A total of 200 patients who underwent robotic mitral regurgitation repair using the da Vinci system (Intuitive Surgical, Inc, Sunnyvale, Calif) between August 2007 and December 2012 were evaluated. Serial echocardiographic results and operative and procedural times were analyzed. Mitral regurgitation repairs were successfully performed, and no or mild residual mitral regurgitation developed in 98.0% of patients, with no conversion to sternotomy. No in-hospital deaths occurred. Follow-up was completed in 96.5% of patients with a median of 31.4 months (interquartile range, months). During follow-up, 4 late deaths, 2 strokes, 1 low cardiac output, 1 newly required dialysis, and 1 reoperation for mitral regurgitation occurred. Freedom from major adverse cardiac events at 5 years was 87.7% ± 5.1%. Regular echocardiographic follow-up (>6 months) was achieved in 187 patients (93.5%). At a median of 29.6 months (interquartile range, months), 21 patients (10.5%) demonstrated moderate or greater mitral regurgitation. Freedom from moderate or greater mitral regurgitation at 5 years was 87.0% ± 2.6%. Mean cardiopulmonary bypass and crossclamping times were ± 48.4 minutes and ± 34.1 minutes, respectively, demonstrating a significant decrease in both times according to the chronologic date of surgery. The authors concluded robotic mitral regurgitation repair is technically feasible and efficacious, demonstrating favorable midterm mitral durability and improved procedural times as experience increases. Robotic Surgery Oct 15 7

8 Zechmeister et al (2014) sought to compare robotic vs laparoscopic surgery in regards to patient reported postoperative pain and quality of life. This was a prospective study of patients who presented for treatment of a new gynecologic disease requiring minimally invasive surgical intervention. All subjects were asked to take the validated Brief Pain Inventory-Short Form at 3 time points to assess pain and its effect on quality of life. Statistical analyses were performed using Pearson x2 and Student's t test. One hundred eleven were included in the analysis of which 56 patients underwent robotic assisted surgery and 55 patients underwent laparoscopic surgery. There was no difference in postoperative pain between conventional laparoscopy and robotic assisted surgery for gynecologic procedures. There was a statistically significant difference found at the delayed postoperative period when evaluating interference of sleep, favoring laparoscopy (ROB 2.0 vs LSC 1.0; P =.03). There were no differences found between the robotic and laparoscopic groups of patients receiving narcotics (56 vs 53, P =.24, respectively), route of administration of narcotics (47 vs 45, P >.99, respectively), or administration of nonsteroidal antiinflammatory medications (27 vs 21, P =.33, respectively). The authors concluded the results demonstrate no difference in postoperative pain between conventional laparoscopy and robotic assisted surgery for gynecologic procedures. Furthermore, pain did not appear to interfere consistently with any daily activity of living. Interference of sleep needs to be further evaluated after controlling for bilateral salpingo-oophorectomy. Manchana et al (2014) sought to determine surgical outcomes, perioperative complications, and patient outcomes in gynecologic cancer patients undergoing robotic surgery. Surgical outcomes, including docking time, total operative time, console time, estimated blood loss (EBL), conversion rate and perioperative complications were retrospectively reviewed in 30 gynecologic cancer patients undergoing robotic surgery. Patient outcomes included recovery time and patient satisfaction, as scored by a visual analogue scale (VAS) from The operations included 24 hysterectomies with pelvic lymphadenectomy (PLD) and/or para-aortic lymphadenectomy, four radical hysterectomies with PLD, and two radical trachelectomies with PLD. Mean docking time was 12.8 ± 9.7 min, total operative time was ± 85.0 min, and console time was ± 78.6 min. These times were decreased in the second half of the cases. There was no conversion rate. Three intraoperative complications, including one external iliac artery injury, one bladder injury, and one massive bleeding requiring blood transfusion were reported. Postoperative complications occurred in eight patients, most were minor. Only one patient had port herniation that required reoperation. Mean hospital stay was 3.5 ± 1.7 days, and recovery time was 14.2 ± 8.1 days. Two-thirds of patients felt very satisfied and one-third felt satisfied; the mean satisfaction score was Two patients with stage III endometrial cancer developed isolated port site metastasis at five and 13 months postoperatively. The authors concluded robotic surgery for gynecologic cancer appears to be feasible, with acceptable perioperative complication rate, fast recovery time and high patient satisfaction. Scientific Rationale Update December 2012 Trevisani et al. (2012) Minimally invasive surgeries such as conventional laparoscopic surgery and robotic assisted laparoscopic surgery (RALS) have significant advantages over the traditional open surgical approach including lower pain medication requirements and decreased length of hospitalization. However, open surgery has demonstrated better success rates and shorter surgery time when compared to the other modalities. Currently, it is unclear which approach has better long-term clinical outcomes, greater benefits. There are limited studies in the literature comparing Robotic Surgery Oct 15 8

9 these three different surgical approaches. In this review, the authors evaluate the advantages and disadvantages of RALS compared to conventional laparoscopic surgery and open surgery for commonly performed pediatric urological procedures such as pyeloplasty, ureteral reimplantation, complete and partial nephrectomy, bladder augmentation and creation of continent catheterizable channels. Although it is not yet possible to demonstrate the superiority of one single surgical modality over another, RALS has been shown to be feasible, well tolerated and advantageous in reconstructive urological procedures. With experience, the outcomes of RALS are improving, justifying its usage. However, there are sill factors limiting the accessibility of RALS, which in the future may improve with device innovation. Scientific Rationale Update December 2011 Mi et al. (2010) conducted a systematic review to assess the feasibility and efficiency of robot assisted laparoscopic fundoplication (RALF) for gastroesophageal reflux disease (GERD). Two reviewers independently searched and identified seven randomized controlled trials (RCTs) and four clinical controlled trials (CCTs) of RALF versus conventional laparoscopic fundoplication (CLF) for GERD. The main outcomes were operating time, complication rate, hospital stay and costs. Of 533 patients, 198 underwent RALF and 335 underwent CLF. The results showed that the postoperative complication rate is lower for RALF, but the total operating time is longer for robot assisted laparoscopic fundoplication compared with those for CLF. Statistically, there was no significant difference between the two groups with regard to perioperative complication rate and length of hospital stay. The authors concluded that while RALF may be a feasible and safe alternative to surgical treatment of GERD, it lacks obvious advantages with respect to operating time and length of hospital stay. Alqahtani et al. (2010) completed a retroreview and evaluated the safety of performing robot-assisted pediatric surgery using the da Vinci Surgical System in a variety of surgical procedures. This study included 144 procedures: 39 fundoplications; 34 cholecystectomies; 25 gastric bandings; 13 splenectomies; 4 anorectal pull-through operations for imperforate anus; 4 nephrectomies; 4 appendectomies; 4 sympathectomies; 3 choledochal cyst excisions with hepaticojejunostomies; 3 inguinal hernia repairs; two of the following: liver cyst excision, repair of congenital diaphragmatic hernia, Heller's myotomy and ovarian cyst excision; and one of the following: duodeno-duodenostomy, adrenalectomy and hysterectomy. A total of 134 procedures were successfully completed without conversion; 7 additional cases were converted to open surgery and 3 were converted to laparoscopic surgery. There were no system failures. There was one esophageal perforation and two cases of transient dysphagia following Nissen fundoplication. The mean patient age was 8.9 years, and the mean patient weight was 57 kg. The authors concluded that robot-assisted surgery appears to be safe and feasible for a number of pediatric surgical procedures. However, further system improvement and randomized as well as comparative studies are necessary to evaluate the benefits, if any, and the long-term outcomes of robotic surgery. The most serious limitation of the available evidence is lack of randomized comparisons of robotic surgery with standard laparoscopic and open surgery. Serious limitations of the studies are small sample sizes and retrospective study designs. Additional studies are needed to establish the efficacy of robotically assisted surgery in children in achieving long-term disease control, and to clarify how it compares with alternative procedures, particularly open surgery and standard laparoscopic surgery, with respect to morbidity, functional outcome, and long-term disease control. Robotic Surgery Oct 15 9

10 Scientific Rationale Update September 2010 In December 2009, the FDA approved the expanded use of the da Vinci Surgical System (Intuitive Surgical, Inc., Sunnyvale, California) to include transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2 (tumors less than 4 cm in greatest dimension without invasion into surrounding structures and no evidence of nodal involvement). According to the FDA, the approval was based on a multicenter retrospective clinical study conducted to confirm the feasibility, efficacy, safety and functional assessment in patients undergoing transoral otolaryngology surgical procedures. Per the FDA, historical controls demonstrate substantial equivalence of robotic assisted transoral procedures to alternative methods of treatment (Open surgery, transoral surgery and chemoradiation treatment). According to Intuitive Surgical, Inc, "da Vinci Transoral Surgery is a safe, effective and minimally invasive procedure that offers throat cancer patients numerous potential benefits over traditional open surgery, including, significantly less blood loss, no visible scarring or disfigurement, no tracheotomy, minimize or eliminate need for chemoradiation therapy, fewer complications, shorter hospital stay, fast recovery, return to normal speech and swallowing and excellent cancer control." They note further, "The potential benefits over traditional open surgery for thyroid cancer include, superior cosmetic outcomes, no neck scars and avoids laryngeal nerve injury." Approximately 275,000 cases of oral cavity cancer are diagnosed worldwide each year, which represents nearly half of the head and neck squamous cell carcinomas (HNSCC) diagnosed. Specific sites of tumor origin include the lip, floor of the mouth, oral tongue (anterior two-thirds of the tongue), lower alveolar ridge, upper alveolar ridge, retromolar trigone (retromolar gingiva), hard palate, and buccal mucosa. Squamous cell cancer (SCC) is the predominant malignancy that occurs in the oral cavity. Either primary surgery or definitive radiation therapy (RT) are options for treatment of early stage oral cavity squamous cell cancer (OCSCC). Surgery is generally the preferred approach in operable patients because it is typically associated with less morbidity than RT. Traditional surgical approaches are generally used as most oral cavity tumors are superficial and easily accessed via the mouth. Definitive RT is reserved for patients who cannot tolerate surgery or for whom surgical resection would result in particularly significant functional loss. Oropharyngeal squamous cell carcinomas (OPSCC) is a relatively uncommon malignancy, with approximately 123,000 cases of oropharyngeal and hypopharyngeal cancer diagnosed worldwide each year. OPSCC refers to tumors involving the soft palate, tonsils, base of tongue, pharyngeal wall, and the vallecula, the fold located between the base of tongue and the epiglottis. Early stage (I and II) cancers of the oropharynx are treated with single modality therapy, either primary surgery or RT. Since the risk of occult neck metastases in the clinically negative neck in patients with OPSCC is relatively high, routine elective neck treatment is generally performed: irradiation for patients treated with primary RT and selective neck dissection for patients treated with primary surgery. According to the National Cancer Institute, "Surgery or radiation are equally successful in controlling Stage 1 and Stage 2 oropharyngeal cancer. Radiation may be the preferred modality where the functional deficit will be great, such as the tongue base or tonsil. Surgery may Robotic Surgery Oct 15 10

11 be the preferred modality where the functional deficit will be minimal, such as tonsil pillar. " For appropriately selected oropharyngeal tumors, minimally invasive alternatives to conventional open surgery, such as transoral laser microsurgery (TLM) and transoral robotic surgery (TORS) have been investigated. Peer review literature is limited and includes a small phase I clinical trial, a few small case series and feasability studies. Park et al (2010) evaluated the efficacy and feasability of hypopharyngectomy by transoral robotic surgery (TORS) in 10 patients with T1 or T2 pyriform sinus cancer and posterior pharyngeal wall cancer. The investigators evaluated the robotic set up time, robotic operation time, blood loss, surgical margins, swallowing time, decannulation time, and surgery related complications. Transoral robotic hypopharyngectomy was performed successfully in all 10 patients. The mean robotic operation time was 62.4min, and an average of 17.5min was required for the setting of the robotic system. There was no significant perioperative complication in the cases. Swallowing function returned to all patients within 8.3 days average. Decannulation was carried out within an average of 6.3days after surgery. The investigators concluded that transoral robotic hypopharyngectomy was feasible and ontologically safe technique for the treatment of early hypopharyngeal cancer, however, no long term oncologic results were reported. Moore et al (2009) investigate the feasibility of transoral robotic surgery as a method of surgical treatment of oropharyngeal squamous cell carcinoma in a prospective case study. Forty-five patients with previously untreated oropharyngeal squamous cell carcinoma underwent transoral robotic surgical removal of the tumor with or without neck dissection and with or without adjuvant therapy. Patients were observed and data were recorded on surgical time, blood loss, surgical complications, tracheostomy tube course, enteral feeding, and resumption of oral diet, speech outcomes, swallowing outcomes, and tumor recurrence. The investigator reported all 45 patients underwent complete transoral robotic surgical excision with simultaneous unilateral or bilateral neck dissection. Margins were negative for tumor. Mean operating time for tumor removal was 71.3 minutes for the last 35 cases. There were 15 stage T1 tumors, 18 T2 tumors, 3 T3 tumors, and 9 T4a tumors. Twenty-six patients had base of tongue primary tumors and 19 had tonsillar fossa tumors. Fourteen patients had a tracheostomy tube placed at surgery, and all patients had their tracheostomy tube removed (mean duration of use, 7.0 days). Twenty-two patients (48.9%) had a nasogastric feeding tube placed, and all patients had their feeding tube removed (mean duration of use, 12.5 days). Eight patients had percutaneous gastrostomy (PEG) tubes placed, and all eight eventually had their PEG tubes removed (mean duration of use, days). Average hospital stay was 3.8 days. There were no major complications and no procedure was aborted because of an inability to remove the tumor. The investigator concluded transoral robotic surgery is a safe and efficacious method of surgical treatment of oropharyngeal neoplasms. Advantages of the technique include adequate ability to visualize and manipulate with two hands lesions in the base of tongue. Patients were able to retain or rapidly regain oropharyngeal function in the majority of cases. Again, no long term oncologic results were reported. Iseli et al (2009) evaluated functional outcomes following transoral robotic surgery for head and neck cancer in a case series. 54 of 62 candidate patients underwent transoral robotic tumor resection. Outcomes include airway management, swallowing (MD Anderson Dysphagia Inventory), and enterogastric feeding. Tumors were most Robotic Surgery Oct 15 11

12 commonly oropharynx (61%) or larynx (22%) and T1 (35%) or T2 (44%). Many received radiotherapy (22% preoperatively, 41% postoperatively) and chemotherapy (31%). Endotracheal intubation was retained (22%) for up to 48 hours, tracheostomy less frequently (9%), and all were decannulated by 14 days. Most commenced oral intake prior to discharge (69%) or within two weeks (83%). A worse postoperative Dysphagia Inventory score was associated with retained feeding tube, age>60, higher T stage, laryngeal site, and complications. At a mean 12 months' follow-up, 17 percent retained a feeding tube (9.5% among primary cases). Retained feeding tube was associated with preoperative tube requirement, higher T stage, oropharyngeal/laryngeal site and recurrent/second primary tumor. Complications including airway edema (9%), aspiration (6%), bleeding (6%), and salivary fistula (2%) were managed without major sequelae. The investigators concluded transoral robotic surgery provides an emerging alternative for selected primary and salvage head and neck tumors with low morbidity and acceptable functional outcomes. Patients with advanced T stage, laryngeal or oropharyngeal site, and preoperative enterogastric feeding may be at increased risk of enterogastric feeding and poor swallowing outcomes. Genden et al (2009) evaluated the technical feasibility, safety, and efficacy of transoral robotic surgery (TORS) for a variety of malignant head and neck lesions. 20 patients were enrolled in an institutional review board-approved prospective trial using the davinci surgical robot. Inclusion criteria for the study consisted of adults with early head and neck cancer involving the oral cavity, oropharynx, hypopharynx, and larynx. In 2 cases, access to the tumor was inadequate and the procedure was terminated. In all 18 cases, negative resection margins were achieved. Intraoral reconstruction was performed in 8 patients. Fifteen of 18 patients underwent concomitant unilateral (n = 10) or bilateral (n = 5) selective neck dissections. None of the patients required tracheotomy and there were no intraoperative or postoperative complications. The average setup time was 54.6 minutes (range, minutes), with a precipitous decrease in the setup time as the study progressed. The investigators concluded TORS is a safe, feasible, and minimally invasive alternative to classic open surgery or endoscopic transoral laser surgery in patients with early cancer of the head and neck. With increasing experience, surgical setup as well as operative time will continue to decrease. No long term oncologic results were reported. Weinstein et al. (2007) reported on a phase I prospective clinical trial, evaluating the feasibility of transoral robotic surgery (TORS) radical tonsillectomy. A total of 27 participants were prospectively selected using a volunteer sample. All eligible patients agreed to participate in the study. Patients underwent TORS radical tonsillectomy for previously untreated invasive squamous cell carcinoma of the tonsillar region without free-flap reconstruction, staged neck dissection, and adjuvant therapy. Main outcome measures included final pathologic margin status, need for short- and long-term tracheotomy tube placement, and need for gastrostomy tube feedings among patients with a minimum 6-month follow-up. The incidence of significant postoperative complications was recorded. No mortality occurred. Final margins found to be negative for cancer were achieved in 25 of 27 patients (93%). Surgical complications included 1 case each of postoperative mucosal bleeding, delirium tremens, unplanned tracheotomy for temporary exacerbation of sleep apnea, and hypernasality and 2 cases of moderate trismus. Twenty-six of 27 patients (96%) were swallowing without the use of a gastrostomy. The investigator concluded radical tonsillectomy using TORS is a new technique that Robotic Surgery Oct 15 12

13 offers excellent access for resection of carcinomas of the tonsil with acceptable acute morbidity. Future reports will focus on long-term oncologic and functional outcomes. The National Comprehensive Cancer Network nor the American Cancer Society do not address transoral robotic surgery in their guidelines on head and neck cancers. The Centers for Medicaid and Medicare does not have a NCD or LCD regarding robotic surgery. In conclusion, there is a lack of evidence in the peer review literature demonstrating the safety and efficacy of transoral robotic surgery. At this time, most of the available published literature is limited to very small feasability studies. There lacks any randomized controlled trials evaluating transoral robotic surgery, or studies comparing transoral robotic surgery to current accepted treatment (i.e., radiation or minimally invasive or open surgery). Long-term controlled trials are needed to determine whether robotically assisted transoral surgery for malignancies results in similar rates of cure or remission and improvements in clinical outcomes. Clinical trials are ongoing. A NCI sponsored phase I trial, "Transoral Robotic Surgery or Standard Surgery in Treating Patients With Benign or Malignant Tumors of the Larynx and Pharynx" was due for completion in May of Other trials are currently recruiting participants and can be accessed at: Scientific Rationale Update October 2007 Robotic-assisted surgery continues to be one of the latest innovations in the field of minimally invasive surgery. The da Vinci robotic system has recently been proposed for minimally invasive laparoscopic hysterectomy in women who require removal of the uterus for the treatment of conditions such as endometriosis, uterine fibroids, uterine prolapse, and uterine cancer. According to the manufacturer, the da Vinci Hysterectomy, offers numerous potential benefits over traditional approaches to vaginal, laparoscopic or open abdominal hysterectomy, particularly when performing more challenging procedures like radical hysterectomy for gynecologic cancer. The company states that potential benefits include significantly less pain, less blood loss, fewer complications, less scarring, shorter hospital stay and a faster return to normal daily activities. Published peer review literature is limited. Advincula and Song (2007) reported that computer-assisted or robotic technology in minimally invasive gynecologic surgery has increased. They note advantages of the robotic approach are the improved dexterity and precision of the instruments coupled with three-dimensional imaging. Limitations include the absence of haptic (tactile) feedback, bulkiness of the system, lack of vaginal access, and cost. They report that experience is still in its infancy, and prospective trials are needed to compare the efficacy against conventional laparoscopy and to help determine not only who should be doing robotic-assisted surgery but also for which applications. In a case series reported by Nezhat et al. (2006), fifteen patients underwent a variety of gynecologic surgeries, such as myomectomies, treatment of endometriosis, total and supracervical hysterectomy, ovarian cystectomy, sacral colpopexy, and Moskowitz procedure. The assembly time to switch from laparoscopy to robotic-assisted surgery was 18.9 minutes and the disassembly time was 2.1 minutes. Robotic-assisted laparoscopy acts as a bridge between laparoscopy and laparotomy but has the disadvantage of being costly and bulky. The investigator Robotic Surgery Oct 15 13

14 reported that robotic-assisted laparoscopic surgeries have advantages in providing a 3-dimensional visualization of the operative field, decreasing fatigue and tension tremor of the surgeon, and added wrist motion for improved dexterity and greater surgical precision. The disadvantages include enormous cost and added operating time for assembly and disassembly and the bulkiness of the equipment. Reynolds et al. (2006) assessed outcomes in sixteen patients who underwent robotassisted laparoscopic hysterectomy. There were no conversions to laparotomy. The mean uterine weight was g. Median operating time was 242 minutes. Average estimated blood loss was 96 ml. One patient experienced a delayed thermal bowel injury, 2 developed postoperative infections, and 1 developed a vaginal cuff hematoma that was managed expectantly. The median length of hospital stay was 1.5 days. The authors concluded that robot-assisted laparoscopic hysterectomy is a feasible and promising new technique that may overcome surgical limitations seen with conventional laparoscopy. Beste et al. (2005) reported on 10 total laparoscopic hysterectomies performed with the use of the da Vinci Robotic Surgical System. The authors reported that operative results were similar to those of standard laparoscopic hysterectomy. They noted advantages over existing standard laparoscopy included tasks like lysis of adhesions, suturing, and knot tying were enhanced with the robotic surgical system. In another case series of eleven patients who underwent laparoscopic hysterectomy and bilateral salpingo-oophorectomy using a computer-enhanced surgical robot, Diaz-Arrastia et al. (2002), reported that it was feasible and well tolerated in this series of patients. Robotically assisted hysterectomy is in the early stage of development. The published studies to date are small, non-randomized, short-term case series and retrospective reviews primarily providing information about the feasibility of using the da Vinci surgical system to perform hysterectomies. Some trends were noted in the outcomes reported in these case series. There is insufficient evidence in the published peer review literature to determine the efficacy or potential harmful effects of robotic surgery compared with conventional open or laparoscopic hysterectomy. There lacks any large comparative studies to traditional laparoscopic procedures. In addition, patient selection has yet to be defined. At this time, robotically assisted hysterectomy is considered investigational and therefore not medically necessary. Additional well-designed studies are required with a larger patient population to compare the clinical efficacy of robotically assisted laparoscopic hysterectomy versus standard laparoscopic hysterectomy. Scientific Rationale Update March 2007 Robotic-assisted orthopedic surgery, requires the use of a surgical robot, which may or may not involve the direct role of a surgeon during the procedure. A robot is defined as a computerized system with a motorized construction (usually an arm) capable of interacting with the environment. The robotic arms are equipped with a variety of surgical instruments, a miniature video camera and flexible wrists that will allow them to duplicate the motion of surgeon s wrists. In its most basic form, it contains sensors, which provide feedback data on the robot s current situation, and a system to process this information so that the next action can be determined. One key advantage of robotic-assisted orthopedic surgery over computer-assisted orthopedic surgery is its accuracy and ability to repeat identical motions. Robotic Surgery Oct 15 14

15 Robotic surgery can be further divided into three subcategories depending on the degree of surgeon interaction during the procedure: 1. Supervisory-controlled In a supervisory-controlled system, the procedure is executed solely by the robot, which will act according to the computer program that the surgeon inputs into it prior to the procedure. The surgeon is still indispensable in planning the procedure and overseeing the operation, but does not partake directly. 2. Telesurgical A telesurgical system, also known as remote surgery, requires the surgeon to manipulate the robotic arms during the procedure rather than allowing the robotic arms to work from a pre-determined program. Using real-time image feedback, the surgeon is able to operate from a remote location using sensor data from the robot. Because the robot is still technically performing the procedure, it is considered a subgroup of robotic surgery. The da Vinvi Surgical System, the current leading device in this field, belongs to this section of robotic surgery. 3. Shared control This system has the most surgeon involvement. The surgeon carries out the procedure with the use of a robot that offers steadyhand manipulations of the instrument. This enables both entities to jointly perform the tasks. Honl et al (2003) performed a study to compare robotic-assisted implantation of a total hip replacement with conventional manual implantation. One hundred and fiftyfour patients scheduled for total hip replacement were randomly assigned to undergo either conventional manual implantation of an S-ROM prosthesis (eighty patients) or robotic-assisted implantation of such a prosthesis (seventy-four patients). The fiveaxis ROBODOC (investigational device exemption (IDE) approved by FDA Oct. 9,1992) was used for the robotic-assisted procedures. Preoperatively as well as at three, six, twelve, and twenty-four months after surgery, the patients were monitored. X-rays done at these intervals were analyzed for evidence of loosening, prosthetic alignment, and heterotopic ossification. Thirteen (18%) of the seventyfour attempted robotic implantations had to be converted to manual implantations as a result of failure of the system. The duration of the robotic procedures was longer than that of the manual procedures (mean and standard deviation, / compared with / minutes, p < 0.001). Limb-length equality (mean discrepancy, / compared with / cm, p < 0.001) and varusvalgus orientation of the stem (mean angle between the femur and the shaft of the prosthesis, 0.34 degrees +/ degrees compared with 0.84 degrees +/ degrees, p < 0.001) were better after the robotic procedures. However, at six months, slightly more heterotopic ossification was seen in the group treated with robotic implantation. Dislocation was more frequent in the group treated with robotic implantation: it occurred in eleven of the sixty-one patients in that group compared with three of eighty in the other group (p < 0.001). Recurrent dislocation and pronounced limping were indications for revision surgery in eight of the sixty-one patients treated with robotic implantation compared with none of the seventy-eight (excluding two with revision for infection) treated with manual insertion (p < 0.001). Robotic Surgery Oct 15 15

16 Rupture of the gluteus medius tendon was observed during all of the revision operations. In summary, the robotic-assisted technology had advantages in terms of preoperative planning and the accuracy of the intraoperative procedure. Disadvantages were the high revision rate; the amount of muscle damage, which was believed to be responsible for the higher dislocation rate; and the longer duration of surgery. This technology, although promising, must be further developed before its widespread usage can be justified. Siebel et al (2005) completed a study to analyze and report both clinical outcome and hip abductor function following robotic assisted versus conventional total hip arthroplasty. A total of 71 patients, 36 robotic-assisted (CASPAR, Orto-Maquet, Rastatt, Germany) and 35 conventional cementless total hip arthroplasties were followed on average for 18 months regarding incidence of complications, hip abductor function (using a spring-balance), and incidence of Trendelenburg's sign. Average duration of surgery (CASPAR: min; conventional: 51.5 min; p < ) as well as average loss of hemoglobin (CASPAR: 4.5 mg/dl; conventional: 3.3 mg/dl; p = ) differed significantly, whereas the incidence of complications (CASPAR: two dislocations, one sciatic paresis, one deep infection; conventional: one dislocation, two fissures), revision rate (CASPAR: 5.6 %; conventional: 2.9 %), and incidence of heterotopic ossifications (CASPAR: 30.6 %; conventional: 17.1 %) was comparable following both procedures (p > 0.05). Differences between the two groups were also significant regarding hip abductor function (CASPAR: 76.1 %; conventional: 93.8 % of the contralateral hip; p < ) and incidence of Trendelenburg's sign (CASPAR: 61.1 %; conventional: 25.7 %; p = ). In conclusion, the significant functional impairment following robotic assisted THA should be taken critically into consideration prior to initiating such procedure. More long-term studies outlining safety and efficacy are necessary before this type of procedure could be recommended. Applications of robot-assisted orthopedic surgery currently under investigation include total hip and knee replacement, tunnel placement for reconstruction of knee ligaments, and trauma and spinal procedures. Several short-term studies demonstrate the feasibility of robotic applications in orthopedics, however, there are no published long-term data defining the efficacy of robot-assisted orthopedic surgery. Issues of training, safety and long-term efficacy must be addressed before robot-assisted orthopedic surgery becomes widely available. Robot-assisted orthopedic surgery is still very much in its infancy but it has the potential to transform the way orthopedic procedures are done in the future. Although promising, at the present time, robot-assisted orthopedic surgery is still considered not medically necessary and therefore investigational. Scientific Rationale - Initial Laparoscopic surgery is currently performed in a minimally invasive fashion with instruments and viewing equipment inserted into the body through small incisions created by the surgeon. While this minimizes surgical trauma and damage to healthy tissue, and reduces patient recovery time, there are the disadvantages of reduced dexterity, work space, and sensory input, which is only available to the surgeon through a single video image. Surgical use of robotics, or computer-assisted surgical systems (CAS), has evolved over the last 10 years. Using ongoing technological advances in computer software and robotic engineering, robotic surgery is aimed at improving surgical outcomes through increased precision in a setting of minimal invasiveness through intuitive instrument control and depth perception. The surgeon is located in a telesurgical workstation physically remote from the operation site and Robotic Surgery Oct 15 16

17 interacts with the patient through a series of master manipulators, micromanipulators, video imaging, and/or tactile sensors. Remote control and voice activation are the methods by which these surgical robots are controlled. Because all information exchanged between surgeon and patient during robotic surgery is digitized, surgical robotics has also ushered in the era of telesurgery. But a number of significant limitations hamper the wide adoption of this tool in its current form. While many of the medical robotic devices are experimental prototypes involved in initial studies. On July 11, 2000, the FDA cleared the Da Vinci Endoscopic Instrument Control System for marketing in the performance of general surgery, urological surgery, gynecological surgery and thoracic surgery, making it the first robotic system allowed to be used in American operating rooms. Multiple lenses are used to provide a true 3-D view from inside the patient s body. Three robotic arms are inserted; one of the rods is equipped with a camera, while the other two are fitted with surgical instruments that are able to dissect and suture the tissue. These instruments are not directly touched by the surgeon's hands, as in other minimally invasive surgery (MIS) techniques. The robotic arm has a built-in wrist for more human-like flexibility and the surgeon operates the robotic manipulators from joysticks attached to a computer next to the operating table. Initially developed for cardiovascular surgery, both thoracic and abdominal operations have been performed using this system. The da Vinci Surgical System costs $1 million dollars and consists of two primary components: (1) a viewing and control console; and (2) a surgical arm unit. Other robotic surgical systems not yet FDA approved include the Zeus robotic surgical system and the ARTEMIS (Advanced Robotics and Telemanipulator System for Minimally Invasive Surgery). While the ZEUS system, which costs $750,000, has not yet been cleared for American use beyond clinical trials, German doctors have already used the system to perform coronary bypass surgery. The ARTEMIS is still a project under development for both abdominal as well as thoracic MIS. The advantages of robotic systems are unique because they overcome many of the obstacles of laparoscopic or thoracoscopic surgery. They can provide the following: (1) the surgeon holds control of a stable camera-telescope platform, eliminating the dependence from a camera assistant; (2) the surgical field is presented to the surgeon in a 3-D display; (3) the robotic instruments have articulations near the tip that increase the degrees of freedom to function more like a human hand; (4) the system has been programmed to compensate for tremors, so, if the doctor's hand shakes, the computer ignores it and allows for unprecedented control and precision of the mechanical arm; and (5) the console provides a more ergonomic operating position for the surgeon. All together, these computer-enhanced functions add precision and dexterity to the surgeon, particularly when performing microsurgical procedures. However, the robots of today have significant limitations: (1) the lack of tactile feedback and, therefore, the force applied in tissue dissection and suturing must rely on visual cues exclusively; (2) a scant number of instruments are available; (3) the hardware is extremely bulky, heavy, and clutters the operating room easily; and, most importantly, robotic surgery is a new technology and its uses and efficacy have not yet been well established. To date, mostly studies of feasibility have been conducted, and almost no long-term follow up studies have been performed. The use of a computer console to perform operations from a distance opens up the idea of telesurgery, which would involve a doctor performing delicate surgery miles Robotic Surgery Oct 15 17

18 away from the patient. If the doctor doesn't have to stand over the patient to perform the surgery, and can remotely control the robotic arms at a computer station a few feet from the patient, the next step would be performing surgery from locations that are even farther away. If it were possible to use the computer console to move the robotic arms in real-time, then it would be possible for a doctor in California to operate on a patient in New York. A major obstacle in telesurgery has been the time delay between the doctor moving his or her hands to the robotic arms responding to those movements. Currently, the doctor must be in the room with the patient for robotic systems to react instantly to the doctor's hand movements. While there has been rapid growth in minimally invasive surgery over the past ten years, only about 25% of the 15 million surgeries performed annually in the United States are done this way. Computer-assisted technology is propelling minimally invasive surgery forward and is expected to revolutionize the way healthcare is delivered in the next five years. The da Vinci Surgical System has a remarkable safety record. With more than 7,800 surgeries worldwide to date, there have been no reportable adverse events. There are approximately 70 da Vinci Systems now in use in major hospitals and surgical facilities in the United States. At present, the surgeon must go through specialized training with the device in a type of surgical procedure before receiving certification. Radical prostatectomy has maintained a cardinal role in the treatment of localized carcinoma of the prostate. The combination of refinements in surgical technique and better definition of the anatomy have decreased the morbidity from surgery. Nonetheless, concerns about treatment-related side effects remain the primary limitation of surgical therapy for prostate cancer. Laparoscopic prostatectomy, with or without robotic assistance, is playing an increasing role in surgical treatment of prostate cancer. However, the minimally invasive aspect of laparoscopy may have less relevance for radical prostatectomy because the open surgical procedure requires a limited infraumbilical incision. In the present series comparing robotically assisted laparoscopic prostatectomy with open radical retropubic prostatectomy, no difference was seen in postoperative pain, length of stay, or requirement for blood replacement. However, the most important outcome measures are tumor control, continence, and sexual potency. The outstanding visibility and precision afforded by the robotic approach may offer advantages in each of these areas. There are 2 published prospective nonrandomized studies comparing open radical retropubic prostatectomy (ORRP) and robotic prostatectomy (RP). Tewari et al (2003) reported on 100 ORRPs by multiple surgeons and 200 contemporaneous RPs by a single surgeon at the same institution. The operative duration was not different (163 vs 160 min). The blood loss was 910 and 150 ml for ORRP and RP, respectively, and transfusion rate was greater after ORRP (67% vs none). It is to be noted, however, that in the ORRP group, only 11% of patients received banked blood transfusions and the remaining 56% received autologous blood. There were 4 times as many complications after ORRP (20% vs 5%), and the hospital stay was longer (3.5 vs 1.2 days). Ninety-three percent of the RP and none of the ORRP patients were discharged within 24 hours. Positive margins were more frequent after ORRP (23% vs 9%). The most striking finding was that patients who underwent RP achieved continence more quickly than after ORRP, and the 50% return of continence occurred at 44 and 160 days, respectively. Sexual function was also evaluated in patients who classified themselves as having normal preoperative erections and sexual intercourse, and those who had a bilateral nerve-sparing procedure (number unknown). Patients after RP had a more rapid return of erection Robotic Surgery Oct 15 18

19 (50% return at a mean follow-up of 180 days vs 440 days after ORRP). The return of intercourse was also quicker after RP, with half of the patients achieving intercourse at a mean follow-up of 340 days. At the time of analysis, half of the ORRP patients had not yet achieved return of intercourse at 700 days. Of the RP and ORRP patients, 42% and 65%, respectively, used sildenafil. Ahlering et al (2004) internally compared a single surgeon's ORRP (n = 60) and RP (n = 60) after the robotic learning curve had adequately matured. Both groups had similar clinical characteristics. No statistically significant differences were found between groups for pathologic stage, Gleason score, or margin status (16.7% vs 20%). Operative times (skin to skin) were also similar (231 vs 214 minutes). The RP group had a statistically significant advantage for estimated blood loss (103 vs 418 ml), postoperative hemoglobin change (1.6 vs 3.3 mg/dl), and hospital stay (1.02 vs 2.2 days). The rate of postoperative complications was similar for the ORPP and RP groups (6.7% vs 10%). Complete continence (0 pads) at 3 months of follow-up was not statistically different (76% vs 75%). ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery states: Investigational work continues in the development of robotic coronary bypass The major obstacle to a totally endoscopic CABG has been the technical difficulty in the construction of an accurate anastomosis. Considerable effort is under way to develop technology for a facilitated anastomotic device, perhaps avoiding the need for a sutured anastomosis. Robotically assisted coronary artery bypass must be considered a work in progress at this time. Canadian Coordinating Office for Health Technology Assessment (CCOHTA) technology assessment on Computer-Assisted Surgery Using Telemanipulators (February 2004) concluded that: computer-assisted surgical systems show promise as a means of improving the quality of certain surgical procedures. There are only limited data from clinical trials with these systems, though there is initial evidence of their safety and efficacy in some applications, when they are used in centers of excellence, for procedures on carefully selected patients. Neither their efficacy in terms of comparative patient outcomes nor their cost-effectiveness has been established. Advantages from quicker recovery and shorter hospital stays have already been achieved through the introduction of less invasive nonrobotic procedures. The benefit of computer-assisted surgery over the nonrobotic techniques is not clear evidence is incremental; true potential has not been fully explored. Deemed by experts and literature to be investigational. It must be remembered that the explosion in laparoscopic surgery in the early 1990s led to a 10-fold increase in injuries to the common bile duct and raised the profile of learning curves and training of surgeons with new technologies. What must be recognized in learning curves is that there should be multiple objective measures to quantify them. These should be measured both qualitatively and quantitatively, not just in terms of time; telemanipulators have built in software that can allow motion and movement pattern analysis. The new qualitative measures should also reflect long term outcomes. Learning curves should be derived and individuals should be Robotic Surgery Oct 15 19

20 expected to reach a certain level of proficiency in simulation and laboratory-based studies before progression to clinical practice. This training with the robot must also be tailored to nonsurgical staff in the operating theater, especially regarding patient safety and setup. In summary, with the exception of robotic surgery of the prostate, advanced surgical robotic systems offer the promise of a unique combination of advantages over open and conventional laparoscopic approaches, clinical data demonstrating improved outcomes are lacking. Most published papers present case series involving a small number of patients demonstrating the feasibility of robotic technology in performing a specific procedure. Comparative studies of robot-assisted surgery versus standard laparoscopic or open surgery are usually matched cohort studies. They generally show an increased operating time for robot-assisted procedures but with similar rates of conversion, intraoperative and postoperative complications, and mortality in comparison to those of laparoscopic surgery. To date, there is no evidence of benefit in terms of duration of surgery, rate of complications and hospital stay. Consistent long-term follow-up data is missing. The benefit to the patient must be evaluated carefully and proven before this technology can become a widely accepted technique in surgery. For now, it is still considered an "experimental approach". Review History March 2005 April 2006 March 2007 March 2007 October 2007 July 2009 September 2010 March 2011 December 2011 December 2012 December 2013 March 2014 October 2014 October 2015 Medical Advisory Council review No changes Coding Updates Robotic assisted orthopedic surgery is still considered not medically necessary and therefore investigational since there is no peer reviewed published long-term data defining the efficacy of robot-assisted orthopedic surgery. Robotic assisted hysterectomy is considered investigational and therefore not medically necessary due to insufficient evidence in the published peer review literature to determine its efficacy. Scientific rationale updated to support this determination. No changes to policy statement. Added links to specific National Medical Policies for robotic surgery No change to policy statement. Updated scientific rationale regarding transoral robotic surgery. Revised policy statement to note that the use of robot in surgery is not separately reimburseable. Update. Added revised Medicare Table. No revisions. Update no revisions Update no revisions. Added reference to Health Net Medical Policy on Computer Assisted Orthopedic Surgery regarding MAKOplasty Partial Knee Resurfacing or MAKOplasty total hip replacement using the Robotic Arm Interactive Orthopedic System (RIO). Update no revisions. Update no revisions This policy is based on the following evidence-based guidelines: 1. The Society of American Gastrointestinal Endoscopic Surgeons (SAGES). Guidelines for the Surgical Practice of Telemedicine (March, 2004). 2. ACC/AHA 2004 Guideline Update for Coronary Artery Bypass Graft Surgery. Robotic Surgery Oct 15 20